Last Updated: May 10, 2026

VASOPRESSIN IN DEXTROSE 5% Drug Patent Profile


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When do Vasopressin In Dextrose 5% patents expire, and what generic alternatives are available?

Vasopressin In Dextrose 5% is a drug marketed by Gland and is included in one NDA.

The generic ingredient in VASOPRESSIN IN DEXTROSE 5% is vasopressin. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vasopressin In Dextrose 5%

A generic version of VASOPRESSIN IN DEXTROSE 5% was approved as vasopressin by AM REGENT on August 3rd, 2020.

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  • What is the 5 year forecast for VASOPRESSIN IN DEXTROSE 5%?
  • What are the global sales for VASOPRESSIN IN DEXTROSE 5%?
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Summary for VASOPRESSIN IN DEXTROSE 5%
Recent Clinical Trials for VASOPRESSIN IN DEXTROSE 5%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Congressionally Directed Medical Research ProgramsPHASE2
Azevan PharmaceuticalsPHASE2
Assistance Publique Hopitaux De MarseillePHASE3

See all VASOPRESSIN IN DEXTROSE 5% clinical trials

Pharmacology for VASOPRESSIN IN DEXTROSE 5%
Physiological EffectDecreased Diuresis
Vasoconstriction

US Patents and Regulatory Information for VASOPRESSIN IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland VASOPRESSIN IN DEXTROSE 5% vasopressin SOLUTION;INTRAVENOUS 216963-002 Aug 22, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Vasopressin in Dextrose 5%

Last updated: April 17, 2026

What is the Current Market Landscape for Vasopressin in Dextrose 5%?

Vasopressin in Dextrose 5% (also known as Vasopressin Injection) is an important vasopressor used for vasodilatory shock, vasoconstrictive therapy in diabetes insipidus, and other critical care scenarios. It is marketed predominantly for hospital and emergency use, primarily through injectable formulations. Market presence includes both branded and generic products.

In 2022, global sales of vasopressin formulations were approximately $400 million, with growth forecast at compound annual growth rate (CAGR) of 5% through 2028, driven by increased ICU admissions and expanded indications.

Which Key Factors Shape Market Dynamics?

Regulatory Environment

Regulatory approval impacts product availability and market expansion. Vasopressin formulations require approval from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Existing products are often off-patent, enabling generics to compete, which suppresses prices but increases volume.

Patent and Exclusivity Status

Most branded vasopressin products have lost patent protection, facilitating generic entry. FDA’s placement of bioequivalence standards (ANDA submissions) in the 2010s led to increased generic competition after expiration of patents filed in the early 2000s.

Manufacturing and Supply Chain

Manufacturing complexity due to the precision required for hormone stability maintains high barriers to entry. Supply disruptions during COVID-19 caused temporary shortages, stressing the importance of resilient manufacturing strategies.

Clinical Practices and Adoption

Vasopressin’s use is driven by guidelines for vasodilatory shock and diabetes insipidus. Its role remains essential but competitive with alternatives like norepinephrine and epinephrine, especially in septic shock management.

Competitive Landscape

The market contains multiple generics—20+ approved formulations in the U.S.—and a small number of branded products. Pricing varies across regions, with hospital procurement being the dominant distribution channel. Generic competition has driven prices down, averaging around $20 per vial in the U.S. market.

What Are the Financial Trajectories and Future Revenue Streams?

Revenue Trends (2022-2028 Projection)

Year Estimated Global Sales CAGR (Compound Annual Growth Rate)
2022 $400 million
2023 $420 million 5%
2024 $441 million 5%
2025 $463 million 5%
2026 $486 million 5%
2027 $511 million 5%
2028 $537 million 5%

The consistent growth hinges on increasing ICU admissions, expanding indications, and potentially new formulations or delivery methods.

Key Revenue Drivers

  • Hospital procurement: Bulk purchasing and formulary inclusion influence volume.
  • New indications: Potential expansion into off-label uses or new formulations. Currently, vasopressin remains mainly in ICU protocols.
  • Patent expirations: Accelerate generic penetration, suppress prices but expand total volume.

Market Risks and Opportunities

Risks include regulatory hurdles, supply disruptions, and competition from alternative vasoconstrictors like norepinephrine. Opportunities involve developing slower-release formulations, safer dosage forms, or combination therapies that extend product life cycles.

How Do Competitive and Regulatory Trends Affect Financial Outlook?

Regulators encourage biosimilar and generic substitution, leading to price erosions but increased access. The FDA's efforts to streamline approval processes for biosimilars could impact branded product revenues negatively.

Policy shifts promoting cost savings in healthcare push hospitals toward lower-priced generics, compressing profit margins. Conversely, hospitals’ preference for proven efficacy sustains demand.

New formulations offering easier administration or improved safety profiles could command premium pricing. However, regulatory approval for such variants requires significant investment and clinical testing.

What Are Key Takeaways?

  • The vasopressin in Dextrose 5% market is mature, with growth mainly from volume increases.
  • Generic competition dominates, pushing prices down while revenue expands in aggregate.
  • Supply chain resilience and regulatory approvals will shape future revenue.
  • Innovation opportunities exist but face regulatory and clinical hurdles.
  • Overall market expansion expects a steady 5% CAGR through 2028.

FAQs

1. What are the primary clinical uses of vasopressin in hospitals?
Vasopressin is used for vasodilatory shock, diabetes insipidus, and sometimes in cardio-pulmonary resuscitation. Its vasoconstrictive properties help restore blood pressure in critical care settings.

2. How does generic competition influence the market?
Generics dominate procurement, significantly reducing unit prices. This limits profit margins for branded products but increases overall sales volume.

3. What are the significant regulatory challenges?
Regulatory bodies focus on ensuring bioequivalence and safety. New formulations or delivery systems must undergo rigorous clinical evaluation.

4. How does supply chain stability impact revenue?
Disruptions during crises like COVID-19 caused shortages, affecting hospital stocking and sales. Stable supply chains are crucial for consistent revenue.

5. What future innovations could impact the market?
Developing slow-release formulations or combination therapies could extend product life and generate premium pricing, depending on regulatory approval and clinical adoption.


Sources

[1] MarketWatch. (2023). Vasopressin Market Trends and Forecasts.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Listings.
[3] EvaluatePharma. (2022). 2022 Global Sales Data for Vasopressin.
[4] FDA. (2020). Guidance for Industry on Generic Drug Development.
[5] IQVIA. (2022). Healthcare and Pharmaceutical Market Data.

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